1
Analyze the Remaining Gaps as Data Exchange is Expanded
to Broader Stakeholder Groups in Support of Innovation
Session INT3, February 11, 2019
Steven Lane, MD, MPH, FAAFP
Clinical Informatics Director - Privacy, Information Security & Interoperability, Sutter Health
2
Steven Lane, MD, MPH, FAAFP has no conflicts of interest to
report
Conflict of Interest
3
The push for advancing interoperability and increased demand
for health information exchange has given rise to expanding
stakeholder groups
This has exposed a variety of gaps in data exchange
In this session, we will identify and explore what gaps exist and
discuss innovative ways in which data is being exchanged to
help diminish these gaps
Presentation Purpose
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1. Identify barriers in data reciprocity and data exchange when it
comes to expanding stakeholder groups
2. Recognize the impact of stakeholder gaps in regards to patient
and value-based care
3. Describe innovative ways in which some stakeholders are
addressing disparities in data exchange
Learning Objectives
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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• Definitions
• Degrees of Interoperability
• Benefits
Background
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“The term ‘interoperability’, with respect to health information
technology, means health information technology that –
a. enables the secure exchange of electronic health information
with, and use of electronic health information from, other health
information technology without special effort on the part of the
user
b. allows for complete access, exchange, and use of
all electronically accessible health information for
authorized use under applicable State or Federal law
c. does not constitute information blocking as defined in section
3022(a) of the Public Health Service Act as amended
21
st
Century Cures Act
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• Interoperability is the ability of different information systems,
devices or applications to connect, in a coordinated manner,
within and across organizational boundaries to access, exchange
and cooperatively use data amongst stakeholders, with the goal of
optimizing the health of individuals and populations
HIMSS, Defining Interoperability in the Health Ecosystem
– Available for public comment until March 23, 2019
– https://www.himss.org/library/interoperability-standards/what-is-interoperability
HIMSS
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• Technical
– Foundational connectivity
• Syntactic – Data Liquidity
– Common data formatting
– Maintain field level interpretation
• Semantic – Data Portability
– Codified data mapped to standard vocabularies
– Maintain meaning
• Functional – Data Utility
– Integration into local workflows, clinical, and analytical processes
Degrees of Interoperability
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• Triple Aim
– Value – Quality / Cost
– Health – individual, population
– Satisfaction / experience – patient, provider, care team
• Impact on care
– Direct patient care
– Population health management
• Value based care: Alignment of incentives > exchange
• Patient safety
– 250,000 deaths / year due to preventable medical errors
Benefits of Interoperability
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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• Interoperability Methodologies
• Connectivity Landscape
• Evolving Capabilities
• Metrics
Current State
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• Telephone, postal mail, FAX
• Secure file transfer
• HL7 Version 2 interfaces – PUSH
– Within and between institutions
– Focused use cases: Orders/results, ADT, registry reporting
• Document Exchange – PUSH & PULL
– Clinical Document Architecture (CDA) – HL7 Version 3
– Consolidated CDA (C-CDA) – 12 document types, 70 sections
• Fast Healthcare Interoperability Resources (FHIR
®
) – PULL > PUSH
– Modular data element exchange
– Supports Application Programming Interfaces (APIs)
Interoperability Methodologies
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• Health Information Exchanges (HIEs)
– Centralized data stores +/- value added services
– Regional and use-specific (e.g., payers, research)
• Direct Interoperability
– DirectTrust
– Health Information Service Providers (HISPs)
• National networks
– eHealth Exchange
– Single and multi-vendor networks
• Exchange frameworks – Connect networks
– Carequality
– Trusted Exchange Framework & Common Agreement (TEFCA)
Connectivity Landscape
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Evolving Capabilities
Traditional
• Point-to-point
connections
• HL7 V2 interfaces
• Individual and
community trust
agreements
• ADT feeds to central
repositories (HIEs)
• Ad hoc CDA
document query, push
• Individual access:
portal, PDF
Transitional
• HIPAA/HITAC, MU/PI
• Transitions of Care
• Treatment use cases
• Federated
architecture and trust
• Automated queries at
point of care
• Patient summary CCD
• Discrete PAMI data
• Minimum necessary
challenges
• Individual access:
VDT capability, CCD
Innovative
• More:
• Participants
• Use cases
• Discrete data
• C-CDA templates
• Automation
• Pop health bulk
query
• Patient Centered
Data Home
• FHIR: Read > write
• Individual access:
apps / APIs
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While there are, as yet, no accepted standards by which to measure
interoperability, there have been dramatic and progressive
increases in the volume of transactions and the types and utility of
data exchanged
Sources:
• Office of the National Coordinator for Health Information
Technology (ONC) reports
• American Hospital Association (AHA) surveys
• Carequality document exchange metrics
• DirectTrust transaction volume
Metrics
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ONC Measurement Framework
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• 2017 Data:
– 70% of hospitals participated in nationwide HIE networks
– 51% of hospitals had necessary patient data available
from outside of their systems at point of care
• 53% of those organizations able to integrate received
health data into their EHR
• Small, rural, and critical access hospitals had lower rates of using
electronic methods to exchange summary of care records
compared to their counterparts
ONC
19
Hospital Interoperability
AHA Survey
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Patient Access & Exchange
• 72% of hospitals have the capability for patients to electronically
view, download and transmit their health information
AHA Survey
21
Carequality – Document Exchange
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
December 2016 - December 2018
Cumulative total = 114 M
~14M documents exchanged / mo.
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DirectTrust – Transactions
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
2014 2015 2016 2017 2018
110,253,902
Number of Send and Receive Direct Transactions
between Trusted Endpoints by Quarter
~37M Transactions / month
Cumulative total = 607 M
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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Stakeholders Identified in TEFCA-1
PROVIDERS
Professional care providers who
deliver care across the continuum, not
limited to but including ambulatory,
inpatient, long-term and post-acute
care (LTPAC), emergency medical
services (EMS), behavioral health, and
home and community based services
INDIVIDUALS
Patients, caregivers,
authorized representatives,
and family members serving in
a non-professional role
FEDERAL AGENCIES
Federal, state, tribal, and
local governments
TECHNOLOGY DEVELOPERS
Organizations that provide health IT capabilities,
including but not limited to electronic health
records, health information exchange (HIE)
technology, analytics products, laboratory
information systems, personal health records,
Qualified Clinical Data Registries (QCDRs),
registries, pharmacy systems, mobile
technology, and other technology that provides
health IT capabilities and services
PAY ERS
Private payers, employers, and
public payers that pay for
programs like Medicare,
Medicaid, and TRICARE
PUBLIC HEALTH
Public and private organizations and agencies
working collectively to prevent, promote and
protect the health of communities by
supporting efforts around essential public
health services
HEALTH INFORMATION NETWORKS
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• Public Health
– Surveillance and reporting
– Clinical services: health centers, dental, nursing, EMS,
disaster services, shelters, outreach, environmental
– Coroners
• Federal / Government Agencies
– Clinical services:
Corrections, DoD/DHA, Indian Health Serv., Schools, VA
– Research / administration:
AHRQ, CDC, DoC, HHS, HRSA, NIH, NLM, ONC
– Law enforcement
More than meets the eye
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• Small, rural and critical access hospitals and clinics
• Pediatrics – Excluded from Meaningful Use incentive program
• Telehealth
• Non-physicians – Dentistry, Optometry, Audiology, Podiatry
• Therapies – Physical, Occupational, Speech, etc.*
• Behavioral Health *
• Substance abuse treatment
• DME
• EMS
• LTPAC
• Home health
• Complementary care – Naturopaths, chiropractors, acupuncturists, homeopaths, etc.
* Included in 2019 Quality Payment Program
Providers with limited connectivity
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• Research
– Public, private, academic, networks
• Pharmacy
– Retail pharmacies
– Pharmacy Benefit Management
– Pharma companies – e.g., post marketing surveillance
• Insurance
– Life
– Disability
– Casualty
Additional Stakeholders
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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• Evolving/competing standards
• Data Utility
• Other Barriers
Gaps
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• Governance – Varies by technology, network, HIO
• Security and trust – Varies by technology, network, push vs. pull
• Format and transport
– HL7 V2, C-CDA, FHIR – Which to use?
• Content
– Data – SDOs, Information modeling initiatives
– Common Clinical Data Set – Evolving 2014 > 2015 CEHRT standard
– US Core Data for Interoperability (USCDI) glide path – 2019 and beyond
– C-CDA templates
– FHIR – Argonaut profiles, US Core
• Privacy
– Varies by state, data type
– Personal data beyond HIPAA covered entities??
Multitude of Standards
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• Access / view
• Ingest
• Interpret
• Integrate / reconcile
• Incorporate into standard workflows
#WithoutSpecialEffort
Data Utility
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• Economic barriers
– Business models and practices
– Information Blocking – Pending final rulemaking
• Inefficiency
– System design
– Procurement
– Implementation
– Integration
– Support
- Procuring Interoperability: Achieving High-Quality,
Connected and Person-Centered Care, Washington, DC: 2018
Other Barriers
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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• EHR certification program – 2015 Edition requiring patient API access
• Interoperability Standards Advisory
• Interoperability Proving Ground – Implementations
• Tech Lab Standards Coordination
• DRAFT US Core Data for Interoperability (USCDI)
• DRAFT Trusted Exchange Framework & Common Agreement
• PENDING proposed Information Blocking clarifications
• OCR RFI regarding potential changes to HIPAA to improve information
sharing for treatment and care coordination
HHS/ONC Support for Interoperability
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• Meaningful Use > “Promoting Interoperability”
• MyHealthEData
– Blue Button 2.0
• Beneficiary access to CMS claims data via FHIR APIs
• Required use of 2015 Certified EHR Technology (CEHRT)
• Includes patient data access via APIs, exchange of the Common Clinical
Data Set, Patient-directed exchange
– Performance Measures
• Include electronic referral loops, clinical information reconciliation, real
time drug formulary and PDMP queries
• Proposals
– Require interoperability as Medicare Condition of Participation
– Require Medicare Advantage plans to provide Blue Button 2.0 capabilities
CMS Support for Interoperability
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• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Innovations
• Conclusions
Outline
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• Direct
• Consolidated Clinical Document Architecture (C-CDA)
• Fast Healthcare Interoperability Resources (FHIR
®
)
• Provider-Payer data exchange
• Consumer-mediated exchange
…PLUS MANY MORE!
Innovations to close the gaps
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• Broadly implemented to support Transitions of Care (ToC) as required by
Meaningful Use Stage 2
• Successfully implemented innovative use cases:
– Query and push based on ADT events
• Current CCD requested by & sent to ED upon patient arrival
• Care team notifications at time of hospital/ED discharge –
To PCP, care manager, home care team
– Results delivery – without point-to-point interfaces
– Care coordination messaging between care team members
– Closed loop referrals – Now required by CMS
• Cross-organization, cross-vendor
– Fax > Direct conversion – improved security, integration
https://www.directtrust.org/wp-content/uploads/2018/11/Master-List-of-Direct-Interoperability-Success-Stories.pdf
Direct - Beyond ToC
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• Leverages established technical interoperability standards to
facilitate closed loop ambulatory referrals via Direct
– Supports the exchange of clinical and scheduling
information between providers
• Successfully tested across multiple EHR vendors
– Being demoed in the HIMSS Interoperability Showcase
• Future focus:
– Acute to LTPAC transfers
– Insurance pre-authorization
360X
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• Clinicians identified challenges related CCD quality and usability:
– Unacceptably large documents
– Lack of clinical notes
– Desire for encounter-specific documents in addition to
patient summary documents
– Need for document version management
• Carequality-CommonWell Joint Document Content Workgroup
Improving C-CDA Exchange
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• Workgroup Recommendations:
– Implementers shall support encounter-specific documents utilizing
specific C-CDA document templates:
• Progress Note Document – Outpatient encounters
• Discharge Summary Document – Inpatient encounters
– Limit data included in encounter documents to:
• Information generated at the time of the encounter
• Patient level data, e.g., Problems, Medications, Allergies,
reviewed / validated during encounter
– Respect time parameters for encounter document queries
• Supports a consolidated longitudinal view of patient records
including encounters from multiple institutions and vendors
Improving C-CDA Exchange
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• Release 1
1. Consultation Note
2. Continuity of Care Document (CCD)
3. Diagnostic Imaging Report
4. Discharge Summary
5. History and Physical
6. Operative Note
7. Procedure Note
8. Progress Note
9. Unstructured Document
• Content Testing Program
• Release 2
10. Care Plan
11. Referral Note
12. Transfer Summary
C-CDA Document Types
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• Implementing Direct messaging
• Improvements to CCD section contents
• C-CCD Data Quality Initiative
– Analyze received documents for completeness, quality,
adherence to standards
– PAMI data, procedures, vitals
– Focus on critical data access and patient safety
– White Paper: Interoperability Progress and Remaining Data
Quality Barriers of Certified Health Information Technologies
https://www.intersystems.com/isc-resources/wp-content/uploads/sites/24/Interoperability_Progress_
Remaining_Data_Quality_Barriers_Certified_Health_Information_Technologies.pdf
VA Innovations
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• Release 4 – Published January 2, 2019
– Normative standard:
• RESTful API, XML and JSON formats
• Terminology layer, conformance framework
• Basic data types
• Key Patient and Observation Resources
– Future changes will be backward compatible
HL7
®
FHIR
®
®
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Heat Wave: The U.S. is Poised
to Catch FHIR in 2019
87% of hospitals, 57% of clinicians using EHRs certified to use FHIR Release 2
10/01/2018
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• Use cases
– Treatment
• Case management – acute, chronic
• Care coordination
– Healthcare Operations
• Prior authorization
• Quality reporting – HEDIS, STARS
• Formulary management
– Payment
• Utilization and appropriateness of care review
• Risk adjustment – HCC coding
• Claims adjudication
Payer-Provider Data Exchange
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• Policy issues
– Minimum necessary requirements – vary by use case
– Self-pay restrictions
– Release restrictions / confidential data
– Re-purposing data
Payer-Provider Data Exchange
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• Technology solutions
– Central repositories
• Manifest Medex (CA)
– C-CDA exchange
• Carequality
– FHIR
®
• ONC-led FAST Initiative – Governance, policy
• HL7 Da Vinci Project – IGs, reference implementations
– Vendor network solutions
• Moxe Health
• Epic Payer Exchange
Payer-Provider Data Exchange
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Da Vinci Project
Interoperability
Showcase:
9100-49
• Leveraging FHIR
®
for payer-provider data exchange
• High priority use cases to support value based care:
• Quality Measure Collection
• Clinical Data Exchange
• Pre-order Burden Reduction
Health Record
Exchange:
Clinical Data
Exchange
Documentation
Templates and
Coverage
Rules
Gaps in Care &
Information
Coverage
Requirements
Discovery
Performing
Laboratory
Reporting
Data Exchange
for Quality
Measures
Prior-
Authorization
Support
Risk Based
Contract
Member
Identification
In HL7 ballot reconciliation as draft standard
Under active development
Planned 2019 Use Cases
Future Use Case
Alerts:
Notification (ADT),
Transitions in
Care, ER
admit/discharge,…
Patient Cost
Transparency
Chronic Illness
Documentation
for
Risk Adjustment
Health Record
Exchange:
Payer Data
Exchange
50
Consumer-Directed Exchange in
an Evolving App Ecosystem
51
• NewWave Telecom & Technologies
– MyCareAI app – “Standards-based, consumer-controlled health
data convergence hub”
• Participating providers enroll Medicare beneficiaries
• App requests claims history via Blue Button (FHIR)
• Query for clinical data from providers based on claims
• Aggregate and assemble longitudinal patient record
• Evaluate quality metrics, identify risks for patient and population
• Feedback to patient and providers (via regional health
information network)
• Offer services
• www.NewWave.io HIMSS Booth #509
Leveraging Blue Button 2.0
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• SAFE Health
– Initial focus on sexual health, STD testing, and treatment
– Integrate with Dating Apps to incentivize regular testing and
sharing of sexual health status
– Home-grown EHR + interoperability
• Labs for testing > historical data access (FHIR)
• Pharmacies for e-prescribing & delivery (HL7 V2)
• EHRs via Carequality for bidirectional exchange (C-CDA)
• Developing to the Apple Health API (FHIR)
• www.SafeHealth.me
Telehealth Integration
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• Beta launch - January 24, 2018
• 1/16/2019: 167 healthcare organizations offering FHIR API-based
access to data from 3 EHR vendors –AthenaHealth, Cerner, Epic
• LabCorp and Quest lab data access / integration
• Recent user survey: 90% of users endorsed:
“The smartphone solution improved their understanding of their
own health, facilitated conversations with their clinicians, or
improved sharing of personal health information with friends
and family.”
Dameff C, Clay B, Longhurst CA. Personal Health Records:
More Promising in the Smartphone Era? JAMA. 2019;321(4):339-340.
Apple Health Records
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• Patient-facing:
• Service Providers:
• Telehealth
• Care plans,
patient monitoring
Apps using Health Records data
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Patient access to EHR data via APIs
0M
73M
117M
118M
134M
151M
162M
181M
182M
188M
191M
197M
0
50
100
150
200
250
Jan.
'18
Feb. Apr. May Jun. Jul. Aug. Sept. Oct. Nov. Dec. Jan.
'19
Millions
• Source: https://torchinsight.com/
Individuals with potential access to the common clinical data set
information in their EHR(s) via API access
vs. ~80M US iPhone users
57
• Background
• Current State
• Stakeholders
• Gaps
• Federal support
• Improvement / innovation efforts
• Conclusions
Outline
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• WE HAVE:
– Stakeholder engagement
– Mature standards – must continue to evolve
– Increasing Connectivity – varies across users, technologies
– Trust frameworks
• Federal DURSA – eHealth Exchange
• DirectTrust
• Carequality
• SHIEC
• NATE
– Government support
– HIT investment – $9.5B in 2018!
Interoperability is within our reach!
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• WE NEED:
– Interoperability by design
– Vendor development and user implementation to:
• Automate exchange
• Integrate data in workflows
• Extend APIs beyond patient access and use
– Continued evolution of standards: C-CDA, FHIR, Argonaut profiles
– Clarification and enforcement of Information Blocking rules
– Finalize and implement a comprehensive TEFCA
– Implement the proposed USCDI glide path
• “Omics” data Device data
• PGHD SDoH
– To #KillTheFax
Interoperability is within our reach!
60
• With CommonWell and Carequality linked, the biggest technical
obstacle to widespread patient-record sharing has been removed
• The healthcare industry is rapidly approaching the point where an
organization using any of the major acute care/ambulatory EMRs
should be able to easily connect to other provider organizations
with minimal cost and effort
• Today, the biggest barriers preventing widespread participation
are governance and the need for organizations to decide to
participate
KLAS – Interoperability 2018
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• HHS / ONC Federal Advisory Committees – Work Groups and Task Forces
– https://www.healthit.gov/topic/federal-advisory-committees/membership-
application
• ONC FHIR at Scale Taskforce (FAST) – Tiger Teams
– https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Tiger+Teams
• The Sequoia Project – Interoperability Matters Workgroups
– https://sequoiaproject.org/interoperability-matters/
• Carequality – Advisory Committee, Workgroups
– https://carequality.org/get-involved/
• DirectTrust – Task forces
– https://www.directtrust.org/
Opportunities for Participation
